# K111157: CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and GANGLION CELL NORMATIVE DATABASES

- Pathway: 510(k) (Traditional)
- Applicant: Carl Zeiss Meditec, Inc.
- Decided: Jan 19, 2012 after 269 days
- Product code: OBO (Tomography, Optical Coherence)
- Device class: 2
- Regulation: 21 CFR 886.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K012727 (2002). 22 ancestors in all.
24 later devices descend from it; 6 cite it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083291: Cirrus HD-Oct with Retinal Nerve Fiber Layer and Macular Normative Databases, Model 4000, Carl Zeiss Meditec, Inc. (2009) Summary page 1.
- K101223: Spectralis Hra+Oct, Spectralis FA_Oct, Spectralis Icga+ Oct, Spectralis Hra, Spectralis FA, Heidelberg Engineering (2010). Our reading of the summary gave K100223, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Spectralis HRA+OCT”.
- K101505: Rtvue Model Rtvue 100, Optovue, Inc. (2010) Summary page 2.

## Most influential descendants
- K112184: Cirrus Photo (2012), 13 descendants of its own
- K150977: Cirrus HD-Oct (2015), 11 descendants of its own
- K161194: PLEX Elite 9000 SS-OCT (2016), 7 descendants of its own
- K181534: Cirrus HD-Oct (2019), 6 descendants of its own
- K141844: Rescan 700, Callisto Eye (2014), 5 descendants of its own

## Indications for use
The Cirrus HD-OCT is a non-contact, high resolution tomographic and biomicroscopic imaging device. It is indicated for in-vivo viewing, axial cross-sectional, and three-dimensional imaging and measurement of anterior and posterior ocular structures, including cornea, retina, retinal nerve fiber layer, ganglion cell plus inner plexiform layer, macula, and optic nerve head. The Cirrus normative databases are quantitative tools for the comparison of retinal nerve fiber layer thickness, macular thickness, ganglion cell plus inner plexiform layer thickness, and optic nerve head measurements to a database of normal subjects. The Cirrus HD-OCT is intended for use as a diagnostic device to aid in the detection and management of ocular diseases including, but not limited to, macular holes, cystoid macular edema, diabetic retinopathy, age-related macular degeneration, and glaucoma.

Source page: https://510kreport.com/device/K111157
Methodology: https://510kreport.com/methodology